ASCA-CHEK— 510(k) K071711
Substantially EquivalentTechlab Inc., Corporate Research Center
FDA 510(k) clearance K071711 for ASCA-CHEK, Substantially Equivalent on 2007-11-07. Applicant: Techlab Inc., Corporate Research Center. Device class: 2.
Clearance details
- Applicant
- Techlab Inc., Corporate Research Center
- Product code
- Code NBT
- Device class
- Class 2
- Regulation
- 21 CFR 866.5785
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Blacksburg, VA, US
Recent devices under product code NBT
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